Cleared Traditional

K842955 - SICKLE-HEME A/S HETEROZYGOUS CONTROL

K842955 is an FDA 510(k) clearance for SICKLE-HEME A/S HETEROZYGOUS CONTROL, manufactured by Michclone Associates, Inc.. The device is a Class 2 Hematology device with product code GHM cleared through the Traditional 510(k) pathway after a 13-day FDA review.

K842955 · Michclone Associates, Inc. · Hematology device
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Aug 1984
Decision
13d
Days
Class 2
Risk

K842955 is an FDA 510(k) clearance for the SICKLE-HEME A/S HETEROZYGOUS CONTROL. Classified as Test, Sickle Cell (product code GHM), Class II - Special Controls.

Submitted by Michclone Associates, Inc. (Mchenry, US). The FDA issued a Cleared decision on August 9, 1984 after a review of 13 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.7825 - the FDA hematology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Michclone Associates, Inc. devices

FDA 510(k) Submission Details - K842955

510(k) Number K842955 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 27, 1984
Decision Date August 09, 1984
Days to Decision 13 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
100d faster than avg
Panel avg: 113d · This submission: 13d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GHM Device Classification - Class 2, Special Controls

Product Code GHM Test, Sickle Cell
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.7825
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Hematology devices follow this clearance model.

Regulatory Peers - GHM Test, Sickle Cell

All 13
Devices cleared under the same product code (GHM) and FDA review panel - the closest regulatory comparables to K842955.
SICKLE CELL REAGENT SET
K860420 · Sterling Diagnostics, Inc. · Feb 1986
THROMBO SCREEN SICKLE CELL ASSAY SET
K854079 · Pacific Hemostasis · Oct 1985
SICKLING HEMOGLOBIN CONTROLS, NORMAL
K842152 · Isolab, Inc. · Sep 1984
SICKLE HB ASSAY
K841170 · Isolab, Inc. · Apr 1984
SICKLE-HEME A/S CONTROLS & A/A CONTROL
K831871 · Anco Medical Reagents & Assoc. · Jul 1983
SICKLE CELL REAGENT SET
K811828 · Anco Medical Reagents & Assoc. · Aug 1981